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Right now, my understanding is that to produce and get approval for a drug, you need to release its chemical formula and other information about it.

But I wonder if at some point in the future, if the drug companies get too worried about their profits due to genericization in countries like Thailand and Brazil, that they might try to implement some sort of "drug DRM." Rather than making the composition of the drug open, don't release what's actually in it, and just test it as a 'black box,' show empirically through tests that it's effective and reasonably safe, but dope the actual pills with a lot of random substances that make it difficult to reverse-engineer (or have the actual drug only be something that's produced in the body through subtle combinations of various things in the pill, or keep the methods of producing the various chemicals in the pills a secret). I'm sure there are lots of bizarre ways that the drug companies could think up to protect the compositions.

Now, I'm not saying that any of these schemes would be effective at protecting the composition -- if the market for a generic drug is big enough, the labs in Thailand can probably afford to spend a lot of time with a mass spectrometer/gas chromatograph and unravel it, but that doesn't mean the drug companies wouldn't try, and waste a lot of time and effort in the process.

As we've seen in the battles over digital IP, there are a whole lot of things that can end up as collateral damage in the fights between rightsholders who see the gravy train slowing down, and people who want their products at a lower price than is being offered.

Ultimately drug companies do need to make a buck too. How are drug companies supposed to effectively control supply and demand to drive up prices if countries like Brazil just get drugs as they please. I suppose this is also a good argument against outsourcing the production of your drugs to countries that are not within your control or goverments that are not on your payroll.
Sad...

Because developing an AIDs drug costs billions, but making it costs pennies. Merck can already rake in the cash on this stuff from first world countries. This is the "these people would never buy it anyways" subset of piracy, and while it makes sense when we're talking about movies to say "They shouldn't get them at all then", we're talking about lives here.

And Amen to giving more encouragement to the drug industry to further ignore the needs of the developing world. All the majors have pretty much halted work on antibiotics, anti-parasitics, and any other program that's not primarily focused at the health issues of fat white males. I'm not saying that poor people shouldn't have access to drugs, but when it costs $1,000,000,000 to develop a new drug, the investors will require their companies to focus on the needs of paying customers.

>Where do you think the research for the next AIDS drug will come from?

Mostly funded by taxpayers, then handed over to Big Pharma, as usual.

"...the pharmaceutical industry is not especially innovative. As hard as it is to believe, only a handful of truly important drugs have been brought to market in recent years, and they were mostly based on taxpayer-funded research at academic institutions, small biotechnology companies, or the National Institutes of Health (NIH)."The Truth About the Drug Companies by Marcia Angell [nybooks.com]

Year 2001: 5 (five) US citizens die in Anthrax scare. US government immediately starts proceedings for compulsory license [cptech.org] for Cipro, wrestling the patent rights away from foreign company and competitor Bayer. This stance is widely praised as proactive and protecting the precious lives of US citizens.

Year 2007: Tens of thousand of people die in Brazil each year from AIDS because they cannot afford patented medication. Action from Brazil to force compulsory licensing is widely denounced as destroying the worldwide pharma industry, especially by US commentators.

Yes, because lord knows a bunch of politicians are best folk to decide how much 'profit' a company needs, as opposed to the market (which can be cruel but a whole lot less corruptible than your average socialist wannabe).

The Brazilian government could have done this in good faith and entered into negotiations to drive down the prize. Many drug companies already sell cheap "only for Africa" drugs and expect to never turn a profit [bbc.co.uk] on it, it's unlikely that they'd have refused Brazil. Instead the Brazilian government chose the politically expedient route of revoking their patent.

I see that you've been reading the leaflets that the pharmaceuticals have been spreading for years. The truth is that most of the actual research is conducted in labs that receive HUGE amounts of public funding. The the drug companies greatest contribution comes in the development of manufacturing processes.

Take AZT for example. Developed by the National Institutes of Health in the 1960s as a cancer drug, but failed to amount to anything.

Flash-forward to the early 1980s and the frightening early years of the AIDS crisis where there was absolutely nothing in the way of effective treatments for the first six years of the epidemic. It was pure hospice care until the National Cancer Institute took another look at AZT and found that it was the first drug that HIV seemed to respond to. The patent was assigned to Burroughs-Wellcome who paid for drug trials and promptly began selling it two years later. Selling it at a price that made it the most expensive drugs ever marketed ($8,000+ a year per patient) - despite the fact it was developed with public money and was the only treatment available for a rapidly-spreading disease with a 100% mortality rate.

> Brazil wanted to pay what Merck charges Thailand, or $0.65 per pill.> They TRIED to negotiate, and Merck put up a wall.

Doesn't seem much like a negotiation to me. Seems more like a "we're the boss in Brazil, and since you don't want to meet our demands, we'll detonate the nuke^W^W^W take your patent away."

Of course, the Brazilian government is within its rights to do this especially as the article notes, they want to make drugs on their own someday. Ironically, the Indians, who they're importing from right now, are busily *increasing* IP protection for drugs even as Indian drug companies invest more and more in R&D and want legal protections in place to protect those investments. In short, all the Robin Hood-style IP-scoffing* sounds good only until you try your hand at profiting from them.

*I should note that this is quite different from scoffing the RIAA and the MPAA, partly because drug companies do not sic lawyers on patients who consume knockoff drugs.

Remind me again why ANY health-care activity should be for-profit. ANY. Band-aids to heart surgery.
Why is selling food to starving Africans profiteering (which it is), but selling healthcare to people in pain or danger of death, not profiteering?

there is a difference between making a profit and gouging poor people for a drug they need

Right. And in this case, the Brazilian government, whose AIDS policy is a model being copied by other countries worldwide, makes sure every single HIV and AIDS patient in Brazil has the medicines. It therefore has huge bargaining power, because it represents such a large number of patients. The former Health Minister, the man responsible for Brazil's AIDS policy, is José Serra, currently the governor of São Paulo state (think of it as being like holding the offices of governor of California and New York and you start to get an idea of the importance of that post). Before anyone cries for the poor drug companies, there are a few important facts you need to know. First, when Serra was still Health Minister, the drug companies decided to try to make more money since the government was buying up everything. They tried to increase their prices when they were already reaping massive profits (all these drugs are mature products in the "cash cow" phase of the product lifecycle, so the BS "paying for research" argument doesn't fly in this case) at the old price. And now the Brazilian government is asking that Merck charge the same price here as they charge in Thailand. And you can be sure Merck is not selling at that price in Thailand as a public service - they are making a profit there too.
When Serra originally went to the two largest makers of AIDS drugs that sell in Brazil, he showed them that the Brazilian constitution permits the Health Minister to determine that a given epidemic is an emergency situation, and in case of emergencies, the Federal Government, on the recommendation of the Health Minister, can break patents. Serra went to the companies and told them he didn't want to do that, but that they would have to negotiate with him in good faith or he would simply break their patents. As I recall, one went along and the other balked for a time, until they saw that Serra wasn't bluffing and was really going to allow Brazilian pharma companies to manufacture the patented drug. I'm surprised the president had to go this far, but the drug companies may have decided to improve their bottom line by doing a little gouging of AIDS patients in Brazil. I'm proud of the government for not knuckling under to Big Pharma. If only the US government would see that and be shamed into actually standing up to Big Pharma on any issue, any issue at all. Instead, you all (I fled 7 years ago) will have to deal with health care prices spiraling out of control until almost nobody can afford it. I have to tell you I'm happy to be in Brazil, a country that actually cares about its residents' health. Yes, I said RESIDENTS. I'm not even a citizen yet! Brazil isn't xenophobic like the USA either, and does not see me, an immigrant, as some kind of threat or some kind of outsider to be treated like crap. Contrast that with how immigrants are treated in the USA these days... I understand there were huge anti-immigration rallies in the USA last week.

Just a quick disclaimer: I think Serra was one hell of a great Health Minister. In addition to standing up to Big Pharma on AIDS drugs, he was also the one who successfully pushed for a law permitting generic drugs (before him, there were none in Brazil), something you can be sure the price gougers from Big Pharma were opposing every step of the way. Serra was really brave to stand up to them on those two points, and I'm proud of him for doing it. He also worked hard (from the executive branch) with the Brazilian Congress to pass a modern organ donation law in Brazil, basically doing away with the black market for transplantable organs that existed before. All that said, I don't think Serra would be much of a president, and I can't say I'm unhappy he lost in his bid for the presidency in 2002. I suspect he'll run again in 2010, because the current president, who is serving his second consecutive term and is still massively p

Methinks you don't understand what a patent IS. It is a trade in which *both* parties benefit. The goal of patents is to get inventors to publish their results, in part so that the technology doesn't disappear with the death of the inventor, and also to increase the available information which people can learn from and build upon.

The price for them publishing is modest compared to the risk they would take doing it: since they will not be able to maintain a monopoly through trade secrets once they publish (by definition), we grant them a temporary monopoly through threat of force.

The fact that we seem to be living in the freakin' future (where the single greatest cause of death basically amounts to "too much food," no one worries about dingos eating the baby at night, and the streets aren't covered in poo) is testament to the fact that this trade has been mutually, greatly beneficial.

So why not have a different system to make these drugs, one which we all pay for and is owned by nobody where none of the fruits of research and development are anyone's "property". This way we can get the work done, pay people to do it, and distribute what everyone needs on a basis of how sick you are, not how much you can afford to pay. I remain unconvinced that privatizing medical needs is a good idea, just as I remain convinced that privatizing firefighting was a good idea (thankfully reversing that work has been done).

ok i came up with a "reasonable" figure simply by taking what the competition is charging (at minimum the cost of materials and labor, but im sure theres some profit in there too) $0.45 per pill (as stated in tfa), and simply multiply by 2. that gives the brand name competetor 100% or more profit off the pill (say appox $0.45 per pill on the low side). Per http://www.avert.org/worlstatinfo.htm [avert.org] the estimated number of aids infections world wide are:

37.2 million adults and 2.3 million children

37.2+2.3= 39.5 Million so some simple math....45 cents per pill, assume 100 pills per person... $45 per person times 40 Million people 45*40,000,000 equals 1.8 Billion dollars in profit.... thats at a cost of $0.90 per pill, and only assuming each person only needs 100 pills for a lifetime and that the AIDS population doesnt grow...

Would you really hesitate to get Abraxane, the FDA-approved brand-name drug at over $4000 a dose, or Taxol, the generic version of the same molecule that costs $150?

The solution to this is to prevent drug companies from advertising prescription medicines to anyone other than those legally allowed to write prescriptions. I have no idea what Abraxane or Taxol is (although a little research tells me that Paclitaxel is a drug used in the treatment of Cancer, and it branded as Taxol).

If I get a prescription medicine in the UK, I have absolutely no idea what the brand name is. My doctor will never identify it by name, the prescription will say how many milligrams of the chemical name I need, and the pharmacy will fill that with the branded or unbranded equivalents (usually unbranded, in a generic bottle with a label printed by them).

To anyone outside the USA, the whole concept of advertising prescription drugs to the general public seems absurd, and somewhat ironic for a company in the middle of a 'war on drugs.'

The number of years added to the lives of the Brazilians who get this drug at a reduced cost will be subtracted several times over from future AIDS victims who would have otherwise have had better drugs available due to the added research dollars.

There are a few problems with this argument:

1. If Brazil had gotten the drugs for the price they wanted, Merck would still have made a profit, whereas Brazil was not going/able to pay what Merck was asking, so the alternative is no profit, and fewer research dollars.

2. If the pharma companies were not spending money on marketing, their R&D budgets could be doubled.

Also catering to the poor means having to distribute the R&D cost over many more pills, how good you can also sell many more of them, abeit for a much lower price. It nowhere means not being able to make a profit and earn back your R&D.

the US is known for using "abstinence" only, and not providing any barrier methods. that is plain stupid, and defies human nature.

the country with the highest abstinence age, lowest STI rate and highest public awareness is Holland. Sex education starts at 5, and teaches that sex is normal, fun but overall has to be SAFE. and it works. and your system doesnt

The other thing is that it's entirely up to Brazil whether or not they want their legal system to even recognize these patents in the first place. Patents aren't a "natural right" in any sense. As copyrights, patents are tools used by the government to encourage innovation for the benefit of the public. If they are being used in ways that harms the public, then it stands to reason that any government that cares about it's people would take action to correct it.